NCT03637244

Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis for Adoption and Adherence for Black Canadians

Pilot Randomized Controlled Trial of a Decision Support Intervention Adapted for HIV Pre-Exposure Prophylaxis Adoption and Adherence Among African, Caribbean and Black Canadian Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of African, Caribbean and Black (ACB) Canadian patients Aim 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design

Detailed description

Aim 1: Adapt Ottawa Decision Support Framework for the HIV PrEP decisional needs of ACB Canadian patients. Investigators propose a cross-sectional qualitative descriptive study using data collected from key informant interviews with PrEP eligible patients and surveys with health professionals involved in HIV PrEP management. Under this aim two research questions will be investigated. Q1) What factors do ACB Canadian patients consider when deciding whether to adopt HIV PrEP? Q2. How do SDT constructs of autonomy, competence and relatedness influence ACB Canadian's decision-making experiences regarding PrEP adoption? AIM 2. Pilot Test The Adapted Decision-Support Intervention Using a Two-Arm Randomized Controlled Design.Hypothesis testing will be de-emphasized in favor of generating effect size estimates. Under this aim three research questions will be investigated. Preliminary hypotheses include: H1: PrEP decision support increases decision quality in both LDQ and HDQ groups, H2: HDQ + decision-support group more likely to initiate PrEP than HDQ control, H3: HDQ PrEP initiators are more likely than LDQ initiators to have serum levels consistent with adherence at 60-days. Data on decision quality survey and PrEP initiation data will generated by the subject from self-administered assessments via the decision-support app on the study-issued smartphone. Investigators will also collect biological specimens to measure adherence to HIV PrEP at 60-days post enrollment. The study will take place in the Toronto metropolitan area (pop. 2.5 million). Over half (59%) of Canada's ACB population is settled in the province of Ontario. Moreover, the majority (70%) of ACB people in Ontario live in metro Toronto, making it the ideal location for this study. The trial procedures will be conducted at sites within the St. Michael's Hospital (SMH) system, including the SMH Li Ka Shing Knowledge Institute.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
BEHAVIORAL	Decision Support Aid and PrEP for Black Canadians	Ottawa Decision Support Framework Adaptation.Investigators will use the inputs from the qualitative findings, CDC public health guidance and the tenofovir + emtricitabine product monograph to tailor the ODSF for use in the C5TM PrEP decision support web-app.

Timeline

• Start date: 2019-04-09
• Primary completion: 2019-10-15
• Completion: 2020-01-15
• First posted: 2018-08-17
• Last updated: 2019-04-12

Locations

1 site across 1 country: Canada